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Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial.

ABSTRACT: Evidence suggests that systematic reviews are used infrequently by physicians in clinical decision-making. One proposed solution is to create filtered resources so that information is validated and refined in order to be read quickly. Two shortened systematic review formats were developed to enhance their use in clinical decision-making.To prepare for a full-scale trial, we conducted a pilot study to test methods and procedures in order to refine the processes. A recruitment email was sent to physicians practicing full- or part-time in family medicine or general internal medicine. The pilot study took place in an online environment and eligible physicians were randomized to one of the systematic review formats (shortened or full-length) and instructed to read the document. Participants were asked to provide the clinical bottom line and apply the information presented to a clinical scenario. Participants' answers were evaluated independently by two investigators against "gold standard" answers prepared by an expert panel.Fifty-six clinicians completed the pilot study within a 2-month period with a response rate of 4.3 %. Agreement between investigators in assessing participants' answers was determined by calculating a kappa statistic. Two questions were assessed separately, and a kappa statistic was calculated at 1.00 (100 % agreement) for each.Agreement between investigators in assessing participants' answers is satisfactory. Although recruitment for the pilot study was completed in a reasonable time-frame, response rates were low and will require large numbers of contacts. The results indicate that conducting a full-scale trial is feasible.ClinicalTrials.gov NCT02414360 .

SUBMITTER: Perrier L

PROVIDER: S-EPMC4542122 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial.

Perrier Laure L Persaud Nav N Thorpe Kevin E KE Straus Sharon E SE

Implementation science : IS 20150815

<h4>Background</h4>Evidence suggests that systematic reviews are used infrequently by physicians in clinical decision-making. One proposed solution is to create filtered resources so that information is validated and refined in order to be read quickly. Two shortened systematic review formats were developed to enhance their use in clinical decision-making.<h4>Methods</h4>To prepare for a full-scale trial, we conducted a pilot study to test methods and procedures in order to refine the processes. ...[more]

PMID: 26276278

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Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Project description:Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

Project description:BackgroundClinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.Methods/designThis is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.DiscussionThe central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.Trial registrationClinicalTrials.gov ID NCT01514786.

Project description:Purpose We examined whether an educational, shared-decision-making tool designed to empower patients, individualize pain management, and maximize use of nonopioid, over-the-counter analgesics reduces opioid use and waste while maintaining adequate pain relief. Methods We developed an educational, shared-decision-making tool regarding postoperative pain medication for outpatient hand surgery. Patients randomized to groups with and without the tool were surveyed for 4 weeks after surgery. Survey variables included Patient-Reported Outcomes Measurement Information System pain intensity and pain interference scores, as well as the number of oxycodone or over-the-counter pills taken. Results were compared using chi-squared, Wilcoxon rank-sum, and Welch’s t tests. Results Fifty-three patients participated: 25 in the shared-tool group and 28 in the no-tool group. The mean age was 60 years, with more women in the no-tool group than the shared-tool group (n =17 versus 11, respectively). The shared-tool group averaged 6.4 prescribed oxycodone pills, versus 10 for the no-tool group (P < .01). The median numbers of oxycodone pills taken the first week after surgery were 2 (interquartile range, 6) for the shared-tool group and 3 (interquartile range, 6) for the no-tool group (P = .97). Patient-reported outcome measures for pain intensity and pain interference were not significantly different for weeks 1, 3, and 4 after surgery. Pain interference was significantly lower in week 2 in the shared-tool group (difference, −4.4; 95% confidence interval, −8.57 to −0.30; P = .04). Conclusions The shared-tool group had equivalent or better pain control and were prescribed a lower number of opioid pain pills than the no-tool group. Both groups used nonopioid medications, with no difference in the types of over-the-counter medications used. Shared decision-making strategies could be applied to other outpatient orthopedic surgical settings, and may reduce the amount of opioids prescribed without compromising pain control. Type of study/level of evidence Therapeutic II.

Project description:The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.Random assignment to print-based decision aid (n?=?628), web-based interactive decision aid (n?=?625), or usual care (UC) (n?=?626).Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d?=?0.33) and print vs UC (d?=?0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P?=?.009) and significantly more web (P?=?.001) and print (P?=?.03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P?=?.06) and web participants (50.4%; P?=?.10) were not significant. Screening rates at 13 months did not differ significantly among groups.Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.clinicaltrials.gov Identifier: NCT00196807.

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Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial.

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Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial.

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